High‐Dose vs. Standard‐Dose Influenza Vaccine in Older Patients With Hypertension: A Post Hoc Analysis of DANFLU‐1
Year: 2025
Type: article
Abstract: ABSTRACT Patients with hypertension (HTN) face an increased risk of complications and mortality from influenza; a risk that may be modified by influenza vaccination. There is limited evidence on the effectiveness of high‐dose (HD‐IIV) compared with standard‐dose (SD‐IIV) inactivated influenza vaccines in hypertensive individuals. This study, a post hoc analysis of DANFLU‐1, a pragmatic, and open‐label, individually randomized trial of HD‐IIV vs. SD‐IIV conducted during the 2021–2022 influenza season among participants aged 65–79 years. Prespecified outcomes in DANFLU‐1 included hospitalization for influenza or pneumonia, cardiovascular, cardiorespiratory, and respiratory hospitalizations, all‐cause hospitalization, and all‐cause mortality. Outcomes were analyzed as both time‐to‐first and recurrent events. DANFLU‐1 randomized 12 477 participants randomized to HD‐IIV or SD‐IIV, of these 6469 (51.9%) had a history of HTN. HD‐IIV was associated with lower hazards for hospitalizations for pneumonia or influenza, respiratory disease, and all‐cause mortality compared with SD‐IIV and these associations were consistent regardless of HTN status ( p interaction = 0.09, = 0.09, and = 0.59, respectively). HD‐IIV was associated with lower incidence rates of recurrent hospitalizations for pneumonia or influenza and all‐cause hospitalizations compared with SD‐IIV, irrespective of HTN status ( p interaction = 0.09 and = 0.75, respectively). There was evidence of potential effect modification of HD‐IIV vs. SD‐IIV in relation to recurrent respiratory hospitalizations, where the relative effect may be greater among those without vs. with HTN ( p interaction = 0.04). In conclusion, this post hoc analysis of a large‐scale pragmatic trial, HD‐IIV was associated with lower risk of clinical outcomes, including hospitalizations for pneumonia or influenza, all‐cause mortality, and all‐cause hospitalizations irrespective of the presence of HTN. Trial Registration : ClinicalTrials.gov identifier: NCT05048589
Source: Journal of Clinical Hypertension
DOI: 10.1111/jch.70177
Authors: Adam Femerling Langhoff, Niklas Dyrby Johansen, Daniel Modin, Kira Hyldekær Janstrup, Katja Vu Bartholdy, Caroline Espersen, Joshua Nealon, Sandrine Samson, Matthew M. Loiacono, Rebecca Harris, Carsten Schade Larsen, Anne Marie Reimer Jensen, Nino Emanuel Landler, Brian L. Claggett, Scott D. Solomon, Martin J. Landray, Gunnar H. Gislason, Lars Køber, Pradeesh Sivapalan, Jens Ulrik Stæhr Jensen, Tor Biering‐Sørensen
Institutions: University of Copenhagen, Copenhagen University Hospital, Gentofte Hospital, Sanofi (France), Sanofi (United States), Aarhus University Hospital, Brigham and Women's Hospital, Harvard University, University of Oxford, University of Southern Denmark, Rigshospitalet, Steno Diabetes Center Copenhagen
Language: English
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $4,000
Funders: Sanofi, Sanofi Pasteur
OpenAlex ID: W4416224062